MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383062

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system's vent plug was loose and there was leakage.The following was translated from chinese to english: for the same batch of products, after the injection was completed and the high-pressure injection was connected for a few seconds, the isolation plug flew out and the patient's blood spattered, and then the needle was withdrawn.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system's vent plug was loose and there was leakage.The following was translated from chinese to english: for the same batch of products, after the injection was completed and the high-pressure injection was connected for a few seconds, the isolation plug flew out and the patient's blood spattered, and then the needle was withdrawn.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 3080106.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Based on the description of the event, our engineers were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection.The bd pegasus is an infusion only device and is not rated for high pressure injections.Bd encourages the review of the instructions for use included with all pegasus units; bd will continue to track and trend for this issue.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17821303
• MDR Text Key: 324302870
• Report Number: 3014704491-2023-00598
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830626
• UDI-Public: (01)00382903830626
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K200891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383062
• Device Lot Number: 3080106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1